A Multicenter, Double Blind, Placebo-Controlled, Safety and Tolerability Study of BMS-708163 in Patients With Prodromal Alzheimer's Disease
Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of BMS-708163 in the Treatment of Patients With Prodromal Alzheimer's Disease
2 other identifiers
interventional
263
6 countries
64
Brief Summary
The purpose of this study is to determine the safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease over a treatment period of a minimum of 104-weeks. In addition patients will be seen for safety visits at 4 and 12 weeks post treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2009
Typical duration for phase_2
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2009
CompletedFirst Posted
Study publicly available on registry
April 30, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedOctober 12, 2015
September 1, 2015
4.2 years
April 29, 2009
September 23, 2015
Conditions
Outcome Measures
Primary Outcomes (4)
Safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease as measured by adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and Safety Head Magnetic resonance imaging (MRI) findings
Every 12 weeks up to week 220
Safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease as measured by adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and Safety Head Magnetic resonance imaging (MRI) findings
Avagacestat-treated patients will be seen for safety visits at 4 Post Treatment/Study Termination
Safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease as measured by adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and Safety Head Magnetic resonance imaging (MRI) findings
Avagacestat-treated patients will be seen for safety visits at 12 Post Treatment/Study Termination
Safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease as measured by adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and Safety Head Magnetic resonance imaging (MRI) findings
Avagacestat-treated patients will have a 24 week post treatment skin examination by a dermatologist
Secondary Outcomes (1)
Predictive value of Cerebral Spinal Fluid (CSF) biomarkers (Aβ40, and Aβ42, total Tau, total Tau/Aβ42 ratio, phosphorylated Tau) on progression to dementia
Baseline (Week 0), Week 2 (optional), Week 24 and Week 104
Study Arms (2)
Avagacestat (50 mg)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Capsules, Oral, 50 mg, once daily, 104 - 220 Weeks
Eligibility Criteria
You may qualify if:
- Patient meets clinical criteria for prodromal Alzheimer's disease (MMSE 24-30)
- Memory complaint by subject or study partner
- CSF aβ42 levels \< 200pg/mL or Total Tau/aβ42 ratio of ≥ 0.39
- Score of ≤4 on the Modified Hachinski Ischemia Scale
- CT results consistent with Alzheimer's disease
- Medically stable
- years education
- Reliable study partner
- Must be able to swallow capsules
You may not qualify if:
- Premenopausal women
- DSM-IV diagnosis of Dementia History of stroke
- Immunocompromised
- Active peptic ulcer, GI bleed, chronic inflammatory bowel disease, chronic diarrhea or past GI surgery that would impact drug absorption
- Unstable Vitamin B-12 deficiency
- Hematologic or solid malignancy within 5 years
- Geriatric Depression Scale ≥ 6
- Unstable medical condition
- Alcohol or drug abuse history with 12-months of study entry
- Significant drug allergy
- Prisoners, compulsory psychiatric patients, or residents of nursing home or skilled nursing facility at entry
- Any other experimental therapy with 30-days of study entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (64)
University Of Alabama At Birmingham
Birmingham, Alabama, 35294, United States
Pivotal Research Centers
Peoria, Arizona, 85381, United States
21st Century Neurology
Phoenix, Arizona, 85004, United States
Banner Alzheimer'S Institute
Phoenix, Arizona, 85006, United States
Sun Health Research Institue
Sun City, Arizona, 85351, United States
Margolin Brain Institute
Fresno, California, 93720, United States
Collaborative Neuroscience Network, Inc.
Long Beach, California, 90806, United States
Mary S. Easton Center
Los Angeles, California, 90095, United States
Pharmacology Research Institute
Newport Beach, California, 92660, United States
Uc Irvine Medical Center
Orange, California, 92868, United States
Pacific Research Network
San Diego, California, 92103, United States
Affiliated Research Institute
San Diego, California, 92108, United States
University Of California, San Diego
San Diego, California, 92161, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, 91403, United States
Radiant Research, Inc.
Denver, Colorado, 80239, United States
Yale University School Of Medicine
New Haven, Connecticut, 06510, United States
Comprehensive Psychiatric Care
Norwich, Connecticut, 06360, United States
Meridien Research
Brooksville, Florida, 34601, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Md Clinical
Hallandale, Florida, 33009, United States
Compass Research, Llc
Orlando, Florida, 32806, United States
Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
Four Rivers Clinical Research, Inc
Paducah, Kentucky, 42003, United States
Brigham & Women'S Hospital
Boston, Massachusetts, 02115, United States
St Louis University
St Louis, Missouri, 63104, United States
Washington University School Of Medicine
St Louis, Missouri, 63108, United States
Cleveland Clinic Lou Ruvo Center For Brain Health
Las Vegas, Nevada, 89106, United States
Memory Enhancement Center Of Amercia, Inc.
Eatontown, New Jersey, 07724, United States
Robert Wood Johnson Medical School, Umdnj
New Brunswick, New Jersey, 08903, United States
Global Medical Institutes, Llc
Princeton, New Jersey, 08540, United States
Memory Enhancement Center Of Nj, Inc.
Toms River, New Jersey, 08755, United States
Spri Clinical Trials, Llc
Brooklyn, New York, 11235, United States
Nyu Langone Medical Center
New York, New York, 10016, United States
Columbia University
New York, New York, 10032, United States
University Of Rochester Medical Center
Rochester, New York, 14642, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Raleigh Neurology Associates, Pa
Raleigh, North Carolina, 27607, United States
Richard H. Weisler, Md, Pa & Assoc.
Raleigh, North Carolina, 27609, United States
Clinical Trials Of America, Inc.
Winston-Salem, North Carolina, 27103, United States
Wake Forest University School Of Medicine
Winston-Salem, North Carolina, 27157, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Neurology & Neuroscience Center Of Ohio
Toledo, Ohio, 43623, United States
Tulsa Clinical Research, Llc
Tulsa, Oklahoma, 74104, United States
Providence Cognitive Assessment Clinic
Portland, Oregon, 97225, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Butler Hospital
Providence, Rhode Island, 02906, United States
Senior Adults Specialty Research (Sasr)
Austin, Texas, 78757, United States
The University Of Texas
Dallas, Texas, 75390, United States
Dean Foundation For Health Research & Education
Middleton, Wisconsin, 53562, United States
Mcw Clinics At Froedtert Hospital
Milwaukee, Wisconsin, 53226, United States
Local Institution
Calgary, Alberta, T2N 4Z6, Canada
Local Institution
Vancouver, British Columbia, V6T 2B5, Canada
Local Institution
London, Ontario, N6C 5J1, Canada
Local Institution
Toronto, Ontario, M5T 2S8, Canada
Local Institution
Greenfield Park, Quebec, J4V 2J2, Canada
Local Institution
Copenhagen, 2100, Denmark
Local Institution
Turku, 20520, Finland
Local Institution
Toulouse, Cedex 9, 31059, France
Local Institution
Bordeaux, 33076, France
Local Institution
Dijon, 21033, France
Local Institution
Nantes, 44093, France
Local Institution
Rennes, 35033, France
Local Institution
Mölndal, 431 41, Sweden
Local Institution
Stockholm, 141 86, Sweden
Related Publications (1)
Coric V, Salloway S, van Dyck CH, Dubois B, Andreasen N, Brody M, Curtis C, Soininen H, Thein S, Shiovitz T, Pilcher G, Ferris S, Colby S, Kerselaers W, Dockens R, Soares H, Kaplita S, Luo F, Pachai C, Bracoud L, Mintun M, Grill JD, Marek K, Seibyl J, Cedarbaum JM, Albright C, Feldman HH, Berman RM. Targeting Prodromal Alzheimer Disease With Avagacestat: A Randomized Clinical Trial. JAMA Neurol. 2015 Nov;72(11):1324-33. doi: 10.1001/jamaneurol.2015.0607.
PMID: 26414022DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2009
First Posted
April 30, 2009
Study Start
May 1, 2009
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
October 12, 2015
Record last verified: 2015-09